Initiating epoetin-alpha (EPO) 120,000 units (U) every three weeks (Q3W) in patients with chemotherapy (CT)-induced anemia (CIA) and a hemoglobin (Hb) of <11 g/dL

Abstract

19589 Background: Reported here are the final Hb results for the group of patients enrolled under an amendment to a larger study that was the first to compare early vs standard intervention with EPO 120,000 U Q3W in patients with CIA and Hb of 11 to 12 g/dL. The amendment allowed for treatment of patients who had a Hb value <11g/dL at screening. Methods: The larger study was a 16-week open-label randomized study that enrolled patients with non-myeloid malignancy, baseline (BL) Hb =11.0 and =12.0 g/dL, and CT planned for =9 weeks. Patients were randomized (1:1) to receive EPO 120,000 U subcutaneously Q3W immediately (early intervention group, EIG) or when their Hb fell to <11.0 g/dL (standard intervention group, SIG). If, at any dosing visit after the first EPO dose, Hb decreased to <10.0 g/dL, patients were switched to EPO 40,000 U weekly (QW). An amendment was added to the larger study to allow similar patients whose Hb was <11 g/dL at screening to be treated with EPO 120,000 U Q3W. EPO was withheld for Hb >13.0 g/dL at any dosing visit; dose was reduced for Hb >12.0 g/dL or Hb increase >1.5 g/dL in a 3-week period (current prescribing information recommends target Hb not to exceed 12 g/dL). Hb response was analyzed using an observed case approach and Hb data following switch to 40,000 U QW were censored. Results: Fifty patients were enrolled under the amendment. BL characteristics were: mean age, 62.0 years; 67% female; mean Hb 10.1 g/dL. Mean Hb changes over time from BL for patients receiving Q3W dosing are shown in the table . PRBC transfusion rate after 4 weeks on treatment was 24.5%. 18.0% of patients had at least one dose withheld and 22.0% had at least one dose reduction. Five deaths and 6 clinically relevant TVEs were reported. Conclusions: This study shows that EPO is effective in raising Hb when initiated in patients with CIA and a Hb of <11 g/dL at 120,000 U every 3 weeks. Further studies are warranted. No significant financial relationships to disclose. [Table: see text]